U1 Hip System, Hip Stem, Porous Coated, Collarless 1101-1070-C

GUDID 04712602340199

UNITED U1 Hip stem, porous coated, collarless, #7

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis
Primary Device ID04712602340199
NIH Device Record Keyfb9f80a6-ab88-495e-9b34-fa657b1b7800
Commercial Distribution StatusIn Commercial Distribution
Brand NameU1 Hip System, Hip Stem, Porous Coated, Collarless
Version Model Number1101-1070-C
Catalog Number1101-1070-C
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602340199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-02
Device Publish Date2015-10-24

On-Brand Devices [U1 Hip System, Hip Stem, Porous Coated, Collarless]

04712602340199UNITED U1 Hip stem, porous coated, collarless, #7
04712602340182UNITED U1 Hip stem, porous coated, collarless, #6
04712602340175UNITED U1 Hip stem, porous coated, collarless, #5
04712602340168UNITED U1 Hip stem, porous coated, collarless, #4.5
04712602340151UNITED U1 Hip stem, porous coated, collarless, #4
04712602340144UNITED U1 Hip stem, porous coated, collarless, #3
04712602340137UNITED U1 Hip stem, porous coated, collarless, #2.5

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